BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERED WHEELCHAIR

    MDR report key: 2912160 · Received January 11, 2013

    Report

    Report Number
    3004493922-2013-00088
    Event Type
    Malfunction
    Date Received
    January 11, 2013
    Report Date
    January 11, 2013
    Manufacturer
    INVACARE SUZHOU
    Product Code
    ITI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO RMA HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.

    Description of Event or Problem · 1

    (B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. DEALER SAID THE USER CALLED HIM AND SAID THE RIGHT MOTOR JERKS INTERMITTENTLY. MDR FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    18007 POWERED WHEELCHAIR 890.3860 ITI INVACARE SUZHOU M51

    Patients

    Seq Age Sex Outcome Treatment
    1 Other